Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion
PONV
1 other identifier
interventional
68
1 country
1
Brief Summary
The purpose of this study is to clarify whether or not a low-dose propofol infusion can effectively prevent postoperative nausea and vomiting (PONV) in patients who have a documented history of PONV and/or motion sickness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2024
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2023
CompletedFirst Posted
Study publicly available on registry
March 8, 2023
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2025
CompletedApril 2, 2025
March 1, 2025
1.1 years
February 22, 2023
March 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Nausea (urge to vomit) episodes
Number of self-reported nausea episodes
24 hours
Retching (labored, spasmodic, rhythmic contractions of respiratory muscles without expulsion of gastric contents) episodes
Number of self-reported retching episodes
24 hours
Vomiting (forceful expulsion of gastric contents) episodes
Number of self-reported vomiting episodes
24 hours
Secondary Outcomes (16)
Choice of antiemetic- Dexamethasone
24 hours
Number of times dexamethasone administered
24 hours
Choice of antiemetic- Ondansetron
24 hours
Number of times ondansetron administered
24 hours
Choice of antiemetic- Promethazine
24 hours
- +11 more secondary outcomes
Study Arms (2)
Propofol
EXPERIMENTALLow-dose propofol infusion at 25 mcg/kg/min
Placebo
PLACEBO COMPARATORSame volume of 0.9% normal saline as the study group
Interventions
Eligibility Criteria
You may qualify if:
- Undergoing general anesthesia for elective surgery
- Documented history of Patient's self-disclosure of PONV and/or motion sickness during pre-anesthesia discussions
- No documented allergy/adverse reaction to propofol
- English speaking
- At least 18 years of age
You may not qualify if:
- Any anti-nausea medication taken within 24 hours prior to surgery
- Unable to provide consent independently
- Allergy or adverse reaction to propofol
- Emergency surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Penn State Health Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Related Publications (1)
Keck WL, Deng E, Liu WM, Kanekar R, Lomivotrov V, Sharma S. Effect of low-dose propofol infusion with sevoflurane versus propofol-only total intravenous anesthesia on postoperative nausea and vomiting in high-risk patients: a single-blind randomized controlled clinical trial. BMC Anesthesiol. 2026 Jan 28. doi: 10.1186/s12871-026-03649-7. Online ahead of print.
PMID: 41593496DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sonal Sharma, MD
Assistant Professor, Department of Anesthesiology and Perioperative Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Department of Anesthesiology and Perioperative Medicine
Study Record Dates
First Submitted
February 22, 2023
First Posted
March 8, 2023
Study Start
February 1, 2024
Primary Completion
March 12, 2025
Study Completion
March 12, 2025
Last Updated
April 2, 2025
Record last verified: 2025-03